Clinical trials: Lower Limb Deformities
Cerebral Palsy, Muscle Spasticity
Dysport® Pediatric Lower Limb Spasticity Study
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy.
- Conditions
- Cerebral Palsy, Muscle Spasticity, Children
- Trial name
- NCT01249417
- Testing
- Botulinum toxin type A
- Where
- 29 sites in United States, Chile and 4 more
- Volunteers
- 241 people
- Sponsor
- Ipsen
Hallux Limitus
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.
- Trial name
- NCT00717691
- Testing
- Metatarsophalangeal Extension Dynasplint System, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Dynasplint Systems, Inc.
Blepharospasm, Hemifacial Spasm
Post Marketing Surveillance Study of Dysport
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.
- Conditions
- Blepharospasm, Hemifacial Spasm, Cervical Dystonia, Spasmodic Torticollis
- Trial name
- NCT00210431
- Where
- 36 sites in France, Germany and 1 more
- Volunteers
- 783 people
- Sponsor
- Ipsen
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Flat Foot, Lateral Column Lengthening
Evaluation of the Titan 3-D™ Wedge System
Evaluate clinical healing and radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge.
- Conditions
- Flat Foot, Lateral Column Lengthening, Medial Cuneiform Osteotomy
- Trial name
- NCT03421665
- Testing
- Titan 3D Wedge System
- Sponsor
- Paragon 28
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
Osteoarthritis of First Metatarsalphalangeal Joint
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
- Trial name
- NCT00969969
- Testing
- Arthrodesis, Cartiva
- Where
- 12 sites in Canada, United Kingdom
- Volunteers
- 236 people
- Sponsor
- Cartiva, Inc.
Amputation Stump, Amputation
Moisture Management Liner At-Home Evaluation
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Liberating Technologies, Inc.
Lower Extremity Surgery, Bunion
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hernia, Inguinal, Flat Foot
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric…
- Trial name
- NCT03918798
- Testing
- Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
- Where
- 9 sites in Italy, Spain
- Volunteers
- 164 people
- Sponsor
- Sintetica SA
Osteoarthritis, Traumatic Arthritis
A Clinical Investigation of the Vanguard™ Complete Knee System
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity
- Trial name
- NCT00698854
- Testing
- Vanguard™ Complete Knee System, Vanguard™ Patient-Specific Femur
- Where
- 8 sites in United States
- Volunteers
- 552 people
- Sponsor
- Zimmer Biomet
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Blister, Wound of Skin
Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.
This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25.
- Conditions
- Blister, Wound of Skin, Epidermolysis Bullosa, Varicose Ulcer of Lower Limb
- Trial name
- NCT05378997
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Xinnate AB
Hallux Valgus, Hallux Limitus
The Hyalex MTP Study
The HYALEX SLALOM MTP Hemiarthroplasty System consists of a synthetic implant designed to replace the distal metatarsal surface of the great toe for treatment of arthritis .
- Conditions
- Hallux Valgus, Hallux Limitus, Hallux Rigidus
- Trial name
- NCT07538141
- Testing
- MTP Hemiarthroplasty
- Where
- Poland
- Volunteers
- 20 people
- Sponsor
- Hyalex Orthopaedics, Inc.
Hallux Rigidus, Hallux Limitus
Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
The great toe is vital for normal, pain free ambulation. Decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis or Hallux Limitus leading to a painful great…
- Conditions
- Hallux Rigidus, Hallux Limitus, Hallux Valgus, Osteoarthritis
- Trial name
- NCT01284985
- Where
- 4 sites in Czechia, Netherlands and 2 more
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Services
Joint Disease
Gait and Functional Outcomes Study Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants
MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous study which showed the Medial Pivot (MP) system required lower quadriceps activation than subjects implanted with a Posterior stabilized…
- Trial name
- GOLD (NCT02589197)
- Testing
- Group 1 (Medial-Pivot), Group 2 (Posterior-Stabilized)
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- MicroPort Orthopedics Inc.
Osteoarthritis of First Metatarsalphalangeal Joint
Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe
Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.
- Trial name
- MOTION (NCT02978573)
- Testing
- Cartiva
- Volunteers
- 135 people
- Sponsor
- Cartiva, Inc.
Bunion, Metatarsophalangeal Fusion
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
- Conditions
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion, Hindfoot Fusion
- Trial name
- STRIDE (NCT03954639)
- Testing
- EXPAREL 13.3Mg/mL Suspension for Injection, Bupivacaine Hydrochloride
- Sponsor
- Pacira Pharmaceuticals, Inc